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Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

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ClinicalTrials.gov Identifier: NCT01962558
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
MicroTransponder Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Device: VNS Treatment
Device: VNS Control
Enrollment 30
Recruitment Details Sixty-two subjects were screened for inclusion into the study. Nine (9) did not meet inclusion criteria, 15 declined to participate, 3 had medical issues, and 5 were screened but were after the study limit of 30. Thirty subjects were enrolled and implanted with the study device.
Pre-assignment Details  
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Period Title: Overall Study
Started 16 14
Acute Study 16 14
12-Weeks 16 14
Completed 16 14
Not Completed 0 0
Arm/Group Title VNS Treatment VNS Control Total
Hide Arm/Group Description

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
Patients with tinnitus
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
55.9  (7.6) 54.9  (9.1) 55.6  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
1
   6.3%
10
  71.4%
11
  36.7%
Male
15
  93.8%
4
  28.6%
19
  63.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
16
 100.0%
14
 100.0%
30
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description Assess the number of serious adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.
Time Frame 6-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description:

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Overall Number of Participants Analyzed 16 14
Measure Type: Number
Unit of Measure: participants
1 2
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Assess the number of adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.
Time Frame 6-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description:

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Overall Number of Participants Analyzed 16 14
Measure Type: Number
Unit of Measure: participants
11 9
3.Secondary Outcome
Title Change in Minimum Masking Level (MML) in Units of dB (Decibels)
Hide Description Asses the change in minimum masking level (MML) for both groups and compare between the groups.
Time Frame 6-weeks (pre-implant to after 6-weeks of VNS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description:

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Overall Number of Participants Analyzed 16 14
Mean (95% Confidence Interval)
Unit of Measure: dB (decibels)
3.5
(-.4 to 7.5)
-3.8
(-11.9 to 4.1)
4.Secondary Outcome
Title Percent Change in Tinnitus Handicap Inventory (THI)
Hide Description Assess the change in THI score for both groups and compare between the groups. The THI is a questionnaire that asks subjects to assess their perception of their tinnitus by rating each question as a Yes (4 points), No (0 points) or Sometimes (2 points). There are 25 questions, scores are summed, so the scale ranges from 0 to 100. Scores are graded as: Grade 1 - Slight (0-16) Only heard in a quiet environment; Grade 2 - Mild (18-36) Easily masked by environmental sounds and easily forgotten with activities.; Grade 3 - Moderate (38-56) Noticed in presence of background noise, although daily activities can still be performed.; Grade 4 - Severe (58-76) Almost always heard, leads to disturbed sleep patterns and can interfere with daily activities.; Grade 5 - Catastrophic (78-100) Always heard, disturbed sleep patterns, difficulty with any activities.
Time Frame 6-weeks (pre-implant to after 6-weeks of VNS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description:

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Overall Number of Participants Analyzed 16 14
Mean (95% Confidence Interval)
Unit of Measure: percentage change of THI
-17.7
(-28 to -7.3)
-7.3
(-27.5 to 12.7)
5.Secondary Outcome
Title Change in Tinnitus Handicap Questionnaire (THQ)
Hide Description Assess the change in THQ score for both groups and compare between the groups. The THQ is a patient questionnaire with 27 questions with each question having a score from 1 to 100. Scoring includes three factors - Factor 1 (Social, Emotional, Behavioral), Factor 2 (Tinnitus and Hearing), Factor 3 (Outlook). Fifteen questions are included in Factor 1, 8 questions in Factor 2, and 4 questions in Factor 3. A total score is calculated by adding the scores for Factor 1 questions and multiplying by 15/27, adding the scores for Factor 2 and multiplying by 8/27, and adding the scores for Factor 3 and multiplying by 4/27. This is then summed for the total score. Total score ranges from 0 to 100, with higher scores indicating more severe tinnitus.
Time Frame 6-weeks (pre-implant to after 6-weeks of VNS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description:

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Overall Number of Participants Analyzed 16 14
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.5
(-8.3 to 3.3)
-7.5
(-15.8 to .7)
6.Other Pre-specified Outcome
Title Change in Tinnitus Functional Index (TFI)
Hide Description Assess the change in TFI score for both groups and compare between the groups. The TFI has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. There are a total of 25 questions, with a range of 0 to 10 on each item (0 to 250) total. All valid answers are summed, divided by the number of questions which were answered, and multiplied by 10 (0-100 range). Score range from 0 to 100 with higher scores indicating worse tinnitus.
Time Frame 6-weeks (pre-implant to after 6-weeks of VNS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description:

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Overall Number of Participants Analyzed 16 14
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.03
(-7.1 to 3.1)
-7.5
(-15.5 to 0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VNS Treatment VNS Control
Hide Arm/Group Description

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

All-Cause Mortality
VNS Treatment VNS Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VNS Treatment VNS Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      2/14 (14.29%)    
Respiratory, thoracic and mediastinal disorders     
Hoarseness [1]  1/16 (6.25%)  1 1/14 (7.14%)  1
Surgical and medical procedures     
Surgery [2]  0/16 (0.00%)  0 1/14 (7.14%)  1
[1]
Hoarseness due to damage to the vagus nerve; recovers over time.
[2]
Surgery to replace broken lead
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VNS Treatment VNS Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      1/14 (7.14%)    
Respiratory, thoracic and mediastinal disorders     
Coughing  2/16 (12.50%)  2 1/14 (7.14%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: VP Clinical Affairs
Organization: MicroTransponder
Phone: 512-371-4160
Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT01962558     History of Changes
Other Study ID Numbers: MT-T-02
2U44DC010084-04 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2013
First Posted: October 14, 2013
Results First Submitted: August 28, 2017
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018